Structure/Function Claims

Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body (e.g., 'calcium builds strong bones,' 'supports immune health'). They do not require FDA pre-approval, but under 21 CFR 101.93: (1) the manufacturer, packer, or distributor must notify FDA no later than 30 days after first marketing a product that bears the claim, certifying that it has substantiation that the claim is truthful and not misleading; (2) the claim must carry the disclaimer 'This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.' (where the label or labeling bears more than one such claim, each may carry that disclaimer, or one plural disclaimer may be used: 'These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.'; under 101.93(d) the disclaimer sits adjacent to each claim with no intervening material, or each claim ends with a symbol, such as an asterisk, that refers to the same symbol next to the disclaimer; on labels and labeling it appears on each panel or page that bears such a claim, and where it is not adjacent to the claim it must be set off in a box; under 101.93(e) it appears in boldface type no smaller than one-sixteenth inch); and (3) the claim must not be a disease claim, such as a claim to diagnose, mitigate, treat, cure, or prevent a disease.